System, Radiation Therapy, Charged-Particle, Medical
Regulation 892.5050
4510(k)s in 12 months (93 all time)
3recalls in 12 months (58 all time)
55recalls that name a 510(k)
Top companies in LHN
| Company | 510(k)s | Recalls |
|---|---|---|
| Ion Beam Applications S.A. | 13 | 35 |
| Mevion Medical Systems | 4 | 10 |
| Varian Medical Systems | 8 | 0 |
| Hitachi , Ltd. | 4 | 0 |
| Hitachi, Ltd., Health Care Company | 4 | 0 |
| Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha | 2 | 2 |
| Anzai Medical Co., Ltd. | 3 | 0 |
| Brainlab AG | 3 | 0 |
| Hitachi America, Ltd., Particle Therapy Division | 0 | 3 |
| Medcom GmbH | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 23, 2026 | K260597 | VIRTUE QA ProNova Solutions | LHN |
| Jun 11, 2026 | K260174 | PROBEAT-CR Hitachi High-Tech Corp., JP | LHN |
| Apr 23, 2026 | K252815 | ProBeam 360 Proton Therapy System v3.0 Varian Medical Systems, Inc. | LHN |
| Mar 25, 2026 | K253406 | S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) Mevion Medical Systems, Inc. | LHN |
| Sep 12, 2025 | K250986 | S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) Mevion Medical Systems, Inc. | LHN |
| Jun 27, 2025 | K243900 | eMotus Respiratory Motion Management System Empnia, Inc. | LHN |
| May 12, 2025 | K242418 | P-Cure Proton Therapy System (PPTS) P-Cure, Ltd., IL | LHN |
| Jan 12, 2024 | K232032 | PROBEAT-FR Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha, JP | LHN |
| Oct 6, 2023 | K231863 | ProBeam 360° Proton Therapy System v2.0 (Multiroom) Varian Medical Systems, Inc. | LHN |
| Mar 20, 2023 | K221996 | P-Cure Proton Beam Therapy System P-Cure, Ltd., IL | LHN |
| Dec 15, 2022 | K220883 | Small Field Applicator Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha, JP | LHN |
| Dec 1, 2022 | K221791 | ProBeam 360° Proton Therapy System Varian Medical Systems, Inc. | LHN |
| Jul 17, 2020 | K201798 | myQA iON Iba Dosimetry GmbH, DE | LHN |
| Jul 13, 2020 | K201042 | PROBEAT-CR Hitachi , Ltd., JP | LHN |
| Apr 8, 2020 | K200282 | Orfit Aerial Couchtop Orfit Industries NV, BE | LHN |
| Jan 23, 2020 | K191821 | Blue Phantom PT Iba Dosimetry GmbH, DE | LHN |
| Sep 27, 2019 | K191521 | Radiance 330 Proton Beam Therapy System Protom International Holding Corporation | LHN |
| Sep 13, 2019 | K191801 | PROBEAT-CR Hitachi , Ltd., JP | LHN |
| Dec 10, 2018 | K181498 | X-ray Imaging System for the McLaren Proton Treatment System Ehmetdx, LLC | LHN |
| Sep 21, 2018 | K181789 | VeriSuite Medcom GmbH, DE | LHN |
| Aug 15, 2018 | K181676 | Mini Ridge Filter and auxiliary functions for PROBEAT-V Hitachi Ltd. Healthcare Hitachi Works, JP | LHN |
| Dec 27, 2017 | K172848 | MEVION S250i Proton Beam Radiation Therapy Device Mevion Medical Systems | LHN |
| Dec 26, 2017 | K171049 | Real Time Image Gating System for Proton Beam Therapy Systems Hitachi, Ltd. Healthcare, JP | LHN |
| Aug 17, 2017 | K163500 | IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class) Ion Beam Applications S.A., BE | LHN |
| Apr 5, 2017 | K170719 | Anzai Respiratory Gating System Anzai Medical Co., Ltd., JP | LHN |
| Dec 8, 2016 | K162246 | ProNova SC360 Proton Therapy System Pronova Solutions, LLC | LHN |
| Aug 17, 2016 | K160612 | Sumitomo Proton Therapy System Sumitomo Heavy Industries, Ltd., JP | LHN |
| Aug 9, 2016 | K152224 | Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2) Ion Beam Application S.A., BE | LHN |
| Jul 13, 2016 | K161163 | PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory Hitachi , Ltd., JP | LHN |
| Apr 22, 2016 | K160432 | Anzai Respiratory Gating System Anzai Medical Co., Ltd., JP | LHN |
| Apr 21, 2016 | K153614 | PROBEAT-V and accessories Hitachi, Ltd., Health Care Company, JP | LHN |
| Feb 25, 2016 | K160063 | McLaren Proton Therapy System Mclaren Health Care Corporation | LHN |
| Nov 2, 2015 | K152592 | PROBEAT-V Hitachi, Ltd., Health Care Company, JP | LHN |
| Oct 2, 2015 | K152207 | Extended Range Shifter for PROBEAT-V Hitachi, Ltd., Health Care Company, JP | LHN |
| Jun 1, 2015 | K151132 | PROBEAT-V Hitachi, Ltd., Health Care Company, JP | LHN |
| Jul 10, 2014 | K132919 | GANTRY BEAM LINE Ion Beam Applications S.A. | LHN |
| Apr 3, 2014 | K133914 | VERISUITE 1.8, VERISUITE-PARTICLE 1.8, VERISUITE, VERISUITE-PARTICLE Medcom GmbH, DE | LHN |
| Mar 14, 2014 | K134052 | RADIANCE 330 PROTON THERAPY SYSTEM Protom International, Inc. | LHN |
| Jan 10, 2014 | K133191 | PROBEAM PROTON THERAPY SYSTEM Varian Medical Systems | LHN |
| Nov 20, 2013 | K132847 | I2C Ion Beam Applications S.A. | LHN |
| Nov 19, 2013 | K130426 | SUMITOMO PROTON THERAPY SYSTEM Sumitomo Heavy Industries, Ltd. | LHN |
| Feb 21, 2013 | K124002 | VERIFICATION CONSOLE Varian Medical Systems | LHN |
| Jun 4, 2012 | K120676 | S-250 PROTON BEAM RADIATION THERAPY SYSTEM Mevion Medical Systems | LHN |
| Mar 14, 2012 | K112969 | AIR-BAG SYSTEM Niigata Mechatronics Co., Ltd., JP | LHN |
| Jan 25, 2012 | K112981 | SUN 125C IONIZATION CHAMBER Sun Nuclear Corp. | LHN |
| Nov 18, 2011 | K112768 | CALYPSO SYSTEMS WITH DYNAMIC EDGE GATING Calypso Medical Technologies, Inc. | LHN |
| Dec 27, 2010 | K101294 | PT2 VARIAN PROTON THERAPY SYSTEM Varian Medical Systems, Oncology Systems | LHN |
| Sep 30, 2010 | K102373 | CALYPSO SYSTEM WITH DYNAMIC EDGE GATING Calypso Medical Technologies, Inc. | LHN |
| Aug 6, 2010 | K101508 | MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235 Ion Beam Applications S.A. | LHN |
| Jul 21, 2010 | K100766 | IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 235 Ion Beam Applications S.A. | LHN |
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